US2023339922A1PendingUtilityA1

Covalent egfr inhibitors and methods of use thereof

Assignee: DANA FARBER CANCER INST INCPriority: Oct 12, 2020Filed: Mar 28, 2023Published: Oct 26, 2023
Est. expiryOct 12, 2040(~14.2 yrs left)· nominal 20-yr term from priority
C07D 409/14A61P 35/00C07D 235/30C07D 401/04C07D 401/14C07D 403/04C07D 403/14C07D 409/12C07D 413/14C07D 495/04C07D 417/14C07D 487/04C07D 471/04
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Claims

Abstract

The disclosure relates to compounds that act as covalent inhibitors of epidermal growth factor receptor (EGFR); pharmaceutical compositions comprising the compounds; and methods of treating or preventing kinase-mediated disorders, including cancer and other proliferation diseases.

Claims

exact text as granted — not AI-modified
1 . A compound of Formula I:
                       or a pharmaceutically acceptable salt thereof; wherein:
 A is selected from the group consisting of C 6 -C 1O  aryl, 5-10 membered heteroaryl, C 3 -C 10  cycloalkyl, 3-10 membered heterocycloalkyl, 5-10 membered fused bicyclic ring, C 3 -C 10  cycloalkenyl, and 3-10 membered heterocycloalkenyl; 
 Y is selected from the group consisting of absent, CH, C 1 -C 5  alkyl, C 1 -C 5  haloalkyl, and NH; 
 X is selected from the group consisting of absent, C 1 -C 6  alkyl, C 2 -C 6  alkenyl, C 2 -C 6  alkynyl, C 6 -C 10  aryl, 5-10 membered heteroaryl, C 3 -C 10  cycloalkyl, 3-10 membered heterocycloalkyl, C 3 -C 10  cycloalkenyl, and 3-10 membered heterocycloalkenyl, wherein aryl, heteroaryl, cycloalkyl, heterocycloalkyl, cycloalkenyl, and heterocycloalkenyl are each optionally substituted with one, two, or three R 5 ; 
 R 1  is selected from the group consisting of H, halo, CN, OH, NO 2 , C 1 -C 6  alkyl, C 1 -C 6  haloalkyl, C 1 -C 6  alkoxy, C 1 -C 6  alkyl-N(R 7 ) 2 , C 1 -C 6  alkyl-OH, N(R 7 ) 2 , NHC(O)R 7 , C(O)N(R 7 )2, NHC(O)N(R 7 ) 2 , SO 2 N(R 7 ) 2 , OC(O)N(R 7 ) 2 , NHC(O)OR 7 , C 6 -C 1O  aryl, 5-10 membered heteroaryl, C 3 -C 10  cycloalkyl, 3-10 membered heterocycloalkyl, C 3 -C 10  cycloalkenyl, and 4-10 membered heterocycloalkenyl; 
 R 4  is selected from the group consisting of H, halo, OH, CN, NO 2 , NH 2 , NH(C 1 -C 6  alkyl), N(C 1 -C 6  alkyl) 2 , C 1 -C 6  alkyl-N(R 7 ) 2 , C 1 -C 6  alkyl, C 1 -C 6  haloalkyl, C(O)-C 1 -C 6  alkyl, C(O)NH 2 , C(O)NH-C 1 -C 6  alkyl, C 1 -C 6  alkyl-OH, P(O)(C 1 -C 6  alkyl) 2 , C 6 -C 1O  aryl, 5-10 membered heteroaryl, C 3 -C 10  cycloalkyl, and 3-10 membered heterocycloalkyl; wherein C 6 -C 1O  aryl, 5-10 membered heteroaryl, C 3 -C 10  cycloalkyl, and 3-10 membered heterocycloalkyl are each optionally substituted with one or two R 6 ; 
 each R 5  is independently selected from the group consisting of C 1 -C 6  alkyl, OH, CN, NO 2 , C 1 -C 6  haloalkyl, NH 2 , NH(C 1 -C 6  alkyl), N(C 1 -C 6  alkyl) 2 , C 1 -C 6  alkyl-N(R 7 ) 2 , C(O)-C 1 -C 6  alkyl, C(O)NH 2 , C(O)NH-C 1 -C 6  alkyl, C 1 -C 6  alkyl-OH, P(O)(C 1 -C 6  alkyl) 2 , C 6 -C 10  aryl, 5-10 membered heteroaryl, C 3 -C 10  cycloalkyl, and 3-10 membered heterocycloalkyl; 
 each R 2 and R 3  is independently selected from the group consisting of:
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
 
 L 3  is a bond, —NH—, -N(C 1 -C 4  alkyl)-, or C 1 -C 4  alkylene, optionally wherein one or more carbon is independently replaced with —C(O)—, —O—, —S—, -NR L3a -, -NR L3a C(O)-, -C(O)NR L3a -, SC(O)—,C(O)S—, —OC(O)—, —C(O)O—, -NR L3a C(S)—, —C(S)NR L3a —, trans-CR L3b =CR L3b -, cis-CR L3b =CR L3b -, —CsC—, —S(O)—, —S(O)O—, —OS(O)—, -S(O)NR L3a -, -NR L3q S(O)-, —S(O) 2 —, —S(O) 2 O—, —OS(O) 2 —, -S(O) 2 NR L3a -, or -NR L3a S(O) 2 -; 
 R L3a  is hydrogen, C 1 -C 6  alkyl optionally substituted with R 9 , or a nitrogen protecting group; 
 R L3b  is independently, at each occurrence, selected from the group consisting of hydrogen, halogen, C 1 -C 6  alkyl, C 2 -C 6  alkenyl, C 2 -C 6  alkynyl, 3-8 membered cycloalkyl, 3-12 membered heterocycloalkyl, 6-10 membered aryl, and 5-8 membered heteroaryl, wherein alkyl, alkenyl, alkynyl, cycloalkyl, heterocyclyl, aryl, and heteroaryl are optionally substituted with one, two, or three R 9 ; 
 or, alternatively, two R L3b  groups, together with the atoms to which they are attached, form a 3-8 membered cycloalkyl or 4-7 membered heterocycloalkyl, both of which are optionally substituted with one, two, or three R 9 ; 
 each of R E1 , R E2 , R E3 , and R E4  is independently selected from the group consisting of hydrogen, halogen, C 1 -C 6  alkyl, C 2 -C 6  alkenyl, C 2 -C 6  alkynyl, 3-12 membered cycloalkyl, 3-12 membered heterocycloalkyl, 6-12 membered aryl, 5-12 membered heteroaryl, CN, CH 2 OR EE , CH 2 N(R EE ) 2 , CH 2 SR EE , OR EE , N(R EE ) 2 , SR EE , wherein alkyl, alkenyl, alkynyl, cycloalkyl, heterocyclyl, aryl, and heteroaryl are optionally substituted with one, two, or three R 9 ; 
 or, alternatively, R E1  and R E3 , or R E2  and R E3 , or R E1  and R E2  are joined to form 3-8 membered cycloalkyl or 4-7 membered heterocycloalkyl, both of which are optionally substituted with one, two, or three R 9 ; 
 each R EE  is independently selected from the group consisting of hydrogen, SO 2 -6-10 membered aryl, C 1 -C 6  alkyl, C 1 -C 6  alkoxy, C 2 -C 6  alkenyl, C 2 -C 6  alkynyl, 3-8 membered cycloalkyl, 3-8 membered heterocycloalkyl, 6-10 membered aryl, and 5-10 membered heteroaryl, wherein alkyl, alkenyl, alkynyl, cycloalkyl, heterocyclyl, aryl, and heteroaryl are optionally substituted with one, two, or three R 9 ; 
 or, alternatively, two R EE  groups, together with the atom to which they are attached, form 4-7 membered heterocycloalkyl; 
 each Y is independently O, S, CH 2 , or NR E7 ; 
 R E7  is hydrogen, C 1 -C 6  alkyl, CN, or a nitrogen protecting group; 
 each R 9  is independently selected from the group consisting of halo, OH, NH 2 , NH(C 1 -C 6  alkyl), and N(C 1 -C 6  alkyl) 2 ; 
 a is 0, 1, or 2; and 
 z is 1, 2, or 3; 
 alternatively, R 3  is
                     
 wherein n is 0, 1, 2, 3, 4, or 5. 
 
   
     
     
         2 . The compound of  claim 1 , wherein:
 A is selected from the group consisting of phenyl, 5-10 membered heteroaryl, C 3 -C 8  cycloalkyl, 3-8 membered heterocycloalkyl, and 5-9 membered fused bicyclic ring;   X is selected from the group consisting of C 1 -C 3  alkyl, phenyl, and 4-8 membered heterocycloalkyl;   R 1  is selected from the group consisting of H, C 1 -C 3  alkyl, halo, and 5-6 membered heteroaryl;   R 4  is selected from the group consisting of H, halo, and C 1 -C 3  alkyl;   R 2  is selected from the group consisting of
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
   R 3  is
                     
                     
 . 
   
     
     
         3 . (canceled) 
     
     
         4 . The compound of  claim 1 , wherein A is selected from the group consisting of phenyl, piperidine, thiophene, pyrrolidine, isoxazole, pyrrole, pyridine, isothiazole, pyrazole, imidazole, thiazole, indoline, indolizine, isoindoline, pyrrolopyrazine, and oxazole. 
     
     
         5 - 11 . (canceled) 
     
     
         12 . The compound of  claim 1 , wherein X is selected from the group consisting of C 1 -C 4  alkyl, phenyl, azepane, and piperidine. 
     
     
         13 . The compound of  claim 1 , wherein R 1  is selected from the group consisting of H, halo, C 1 -C 3  alkyl, and 5-6 membered heteroaryl. 
     
     
         14 . The compound of  claim 1 , wherein R 4  is selected from the group consisting of H, halo, and C 1 -C 3  alkyl. 
     
     
         15 . (canceled) 
     
     
         16 . The compound of  claim 1 , wherein R 2  is independently selected from the group consisting of:
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
 ; and 
 R 3  is independently selected from the group consisting of:
                     
                     
                     
                     
                     
                     
                     
 and 
                     
 
 wherein n is 1, 2, 3, or 4. 
 
     
     
         17 - 18 . (canceled) 
     
     
         19 . The compound of  claim 1 , wherein the compound of Formula I is a compound of Formula II:
                       or a pharmaceutically acceptable salt thereof.   
     
     
         20 . The compound of  claim 19 , wherein 
 A is phenyl, 5-9 membered heteroaryl, C 3 -C 6  cycloalkyl, 4-9 membered heterocycloalkyl, and 5-9 membered fused bicyclic ring;   R 1  is selected from the group consisting of H, C 1 -C 3  alkyl, halo, and 5-6 membered heteroaryl;   R 4  is selected from the group consisting of H, halo, and C 1 -C 3  alkyl;   R 2  is selected from the group consisting of
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
   R 3  is
                     
                     
                     
   wherein each L 3  is independently a bond, —NH—, or -N(C 1 -C 4  alkyl)-;   each of R E1 , R E2 , R E3 , and R E4  is independently selected from the group consisting of hydrogen, halogen, N(R EE ) 2 , and C 1 -C 6  alkyl;   each Y is independently O, CH 2 , or NR E7 ;   R E7  is CN;   each R EE  is independently hydrogen or SO 2 -6-10 membered aryl optionally substituted with one, two, or three R 9 ;   R 9  is halo;   a is 1 or 2; and   z is 1 or 2.   
     
     
         21 . The compound of  claim 1 , wherein the compound of Formula I is a compound of Formula III:
                       or a pharmaceutically acceptable salt thereof; 
 or a compound of Formula IV:
                     
 or a pharmaceutically acceptable salt thereof. 
 
     
     
         22 . (canceled) 
     
     
         23 . The compound of  claim 21 , wherein 
 X is selected from the group consisting of C 1 -C 3  alkyl, phenyl, and 4-8 membered heterocycloalkyl;   R 1  is selected from the group consisting of H, C 1 -C 3  alkyl, halo, and 5-6 membered heteroaryl;   R 4  is selected from the group consisting of H, halo, and C 1 -C 3  alkyl;   R 2  is selected from the group consisting of
                     
                     
                     
                     
                     
                     
                     
   R 3  is
                     
                     
                     
   wherein each L 3  is independently a bond, —NH—, -N(C 1 -C 4  alkyl)-;   each of R E1 , R E2 , R E3 , and R E4  is independently selected from the group consisting of hydrogen, halogen, N(R EE ) 2 , and C 1 -C 6  alkyl;   each Y is independently O, CH 2 , or NR E7 ;   R E7  is CN;   each R EE  is independently hydrogen or SO 2 -6-10 membered aryl optionally substituted with one, two, or three R 9 ;   R 9  is halo;   a is 1 or 2; and   z is 1 or 2.   
     
     
         24 . The compound of  claim 1 , wherein the compound of Formula I is a compound of Formula V:
                       or a pharmaceutically acceptable salt thereof.   
     
     
         25 . The compound of  claim 24 , wherein 
 X is selected from the group consisting of C 1 -C 3  alkyl, phenyl, and 4-8 membered heterocycloalkyl;   R 1  is selected from the group consisting of H, C 1 -C 3  alkyl, halo, and 5-6 membered heteroaryl;   R 4  is selected from the group consisting of H, halo, and C 1 -C 3  alkyl;   R 2  is selected from the group consisting of
                     
                     
                     
   R 3  is
                     
                     
   wherein each L 3  is independently a bond, —NH—, -N(C 1 -C 4 alkyl)-;   each of R E1 , R E2 , and R E3  is independently selected from the group consisting of hydrogen, halogen, and C 1 -C 6  alkyl;   each Y is independently O or CH 2 ; and   a is 1 or 2.   
     
     
         26 . The compound of  claim 1 , wherein the compound of Formula I is selected from the group consisting of
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             or a pharmaceutically acceptable salt thereof.   
     
     
         27 - 29 . (canceled) 
     
     
         30 . A pharmaceutical composition comprising a compound of  claim 1 , or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier. 
     
     
         31 . A method of inhibiting the activity of EGFR in a subject in need thereof comprising administering to the subject a therapeutically effective amount of a compound of  claim 1 . 
     
     
         32 . A method of treating cancer in a subject in need thereof comprising administering to the subject a therapeutically effective amount of a compound of  claim 1 . 
     
     
         33 . The method of  claim 32 , wherein the cancer is selected from the group consisting of lung cancer, colon cancer, breast cancer, endometrial cancer, thyroid cancer, glioma, squamous cell carcinoma, and prostate cancer. 
     
     
         34 . The method according to  claim 32 , wherein the cancer is non-small cell lung cancer (NSCLC). 
     
     
         35 . A method of inhibiting the activity of EGFR in a subject in need thereof comprising targeting both Cys775 and Cys797 on EGFR. 
     
     
         36 . The method of  claim 35 , wherein the method comprises administering to the subject a therapeutically effective amount of a compound of Formula I:
                       or a pharmaceutically acceptable salt thereof; wherein:
 A is selected from the group consisting of C 6 -C 1O  aryl, 5-10 membered heteroaryl, C 3 -C 10  cycloalkyl, 3-10 membered heterocycloalkyl, 5-10 membered fused bicyclic ring, C 3 -C 10  cycloalkenyl, and 3-10 membered heterocycloalkenyl; 
 Y is selected from the group consisting of absent, CH, C 1 -C 5  alkyl, C 1 -C 5  haloalkyl, and NH; 
 X is selected from the group consisting of absent, C 1 -C 6  alkyl, C 2 -C 6  alkenyl, C 2 -C 6  alkynyl, C 6 -C 10  aryl, 5-10 membered heteroaryl, C 3 -C 10  cycloalkyl, 3-10 membered heterocycloalkyl, C 3 -C 10  cycloalkenyl, and 3-10 membered heterocycloalkenyl, wherein aryl, heteroaryl, cycloalkyl, heterocycloalkyl, cycloalkenyl, and heterocycloalkenyl are each optionally substituted with one, two, or three R 5 ; 
 R 1  is selected from the group consisting of H, halo, CN, OH, NO 2 , C 1 -C 6  alkyl, C 1 -C 6  haloalkyl, C 1 -C 6  alkoxy, C 1 -C 6  alkyl-N(R 7 ) 2 , C 1 -C 6  alkyl-OH, N(R 7 ) 2 , NHC(O)R 7 , C(O)N(R 7 )2, NHC(O)N(R 7 ) 2 , SO 2 N(R 7 ) 2 , OC(O)N(R 7 ) 2 , NHC(O)OR 7 , C 6 -C 1O  aryl, 5-10 membered heteroaryl, C 3 -C 10  cycloalkyl, 3-10 membered heterocycloalkyl, C 3 -C 10  cycloalkenyl, and 4-10 membered heterocycloalkenyl; 
 R 4  is selected from the group consisting of H, halo, OH, CN, NO 2 , NH 2 , NH(C 1 -C 6  alkyl), N(C 1 -C 6  alkyl) 2 , C 1 -C 6  alkyl, C 1 -C 6  haloalkyl, C(O)-C 1 -C 6  alkyl, C(O)NH 2 , C(O)NH-C 1 -C 6  alkyl, C 1 -C 6  alkyl-OH, P(O)(C 1 -C 6  alkyl) 2 , C 6 -C 1O  aryl, 5-10 membered heteroaryl, C 3 -C 10  cycloalkyl, and 3-10 membered heterocycloalkyl; wherein C 6 -C 1O  aryl, 5-10 membered heteroaryl, C 3 -C 10  cycloalkyl, and 3-10 membered heterocycloalkyl are each optionally substituted with one or two R 6   
 each R 5  is independently selected from the group consisting of C 1 -C 6  alkyl, OH, CN, NO 2 , C 1 -C 6  haloalkyl, NH 2 , NH(C 1 -C 6  alkyl), N(C 1 -C 6  alkyl) 2 , C(O)-C 1 -C 6  alkyl, C(O)NH 2 , C(O)NH-C 1 -C 6  alkyl, C 1 -C 6  alkyl-OH, P(O)(C 1 -C 6  alkyl) 2 , C 6 -C 1O  aryl, 5-10 membered heteroaryl, C 3 -C 10  cycloalkyl, and 3-10 membered heterocycloalkyl; 
 each R 2 and R 3  is independently selected from the group consisting of:
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
 
 L 3  is a bond, —NH—, -N(C 1 -C 4  alkyl)-, or C 1 -C 4  alkylene, optionally wherein one or more carbon is independently replaced with —C(O)—, —O—, —S—, -NR L3a -, -NR L3a C(O)-, -C(O)NR L3a -, SC(O)—,C(O)S—, —OC(O)—, —C(O)O—, -NR L3a C(S)—, —C(S)NR L3a —, trans-CR L3b =CR L3b -, cis-CR L3b =CR L3b -, —C≡C—, —S(O)—, —S(O)O—, —OS(O)—, -S(O)NR L3a -, -NR L3a S(O)-, —S(O) 2 —, —S(O) 2 O—, —OS(O) 2 —, -S(O) 2 NR L3a -, or -NR L3a S(O) 2 -; 
 R L3a  is hydrogen, C 1 -C 6  alkyl optionally substituted with R 9 , or a nitrogen protecting group; 
 R L3b  is independently, at each occurrence, selected from the group consisting of hydrogen, halogen, C 1 -C 6  alkyl, C 2 -C 6  alkenyl, C 2 -C 6  alkynyl, 3-8 membered cycloalkyl, 3-12 membered heterocycloalkyl, 6-10 membered aryl, and 5-8 membered heteroaryl, wherein alkyl, alkenyl, alkynyl, cycloalkyl, heterocyclyl, aryl, and heteroaryl are optionally substituted with one, two, or three R 9   ;   
 or, alternatively, two R L3b  groups, together with the atoms to which they are attached, form a 3-8 membered cycloalkyl or 4-7 membered heterocycloalkyl, both of which are optionally substituted with one, two, or three R 9 ; 
 L 4  is a bond or C 1 -C 6  alkyl optionally substituted with one, two, or three R 9 ; 
 each of R E1 , R E2 , R E3 , and R E4  is independently selected from the group consisting of hydrogen, halogen, C 1 -C 6  alkyl, C 2 -C 6  alkenyl, C 2 -C 6  alkynyl, 3-12 membered cycloalkyl, 3-12 membered heterocycloalkyl, 6-12 membered aryl, 5-12 membered heteroaryl, CN, CH 2 OR EE , CH 2 N(R EE ) 2 , CH 2 SR EE , OR EE , N(R EE ) 2 , SR EE , wherein alkyl, alkenyl, alkynyl, cycloalkyl, heterocyclyl, aryl, and heteroaryl are optionally substituted with one, two, or three R 9 ; 
 or, alternatively, R E1  and R E3 , or R E2  and R E3 , or R E1  and R E2  are joined to form 3-8 membered cycloalkyl or 4-7 membered heterocycloalkyl, both of which are optionally substituted with one, two, or three R 9 ; 
 each R EE  is independently selected from the group consisting of hydrogen, C 1 -C 6  alkyl, C 1 -C 6  alkoxy, C 2 -C 6  alkenyl, C 2 -C 6  alkynyl, 3-8 membered cycloalkyl, 3-8 membered heterocycloalkyl, 6-10 membered aryl, and 5-10 membered heteroaryl, wherein alkyl, alkenyl, alkynyl, cycloalkyl, heterocyclyl, aryl, and heteroaryl are optionally substituted with one, two, or three R 9 ; 
 or, alternatively, two R EE  groups, together with the atom to which they are attached, form 4-7 membered heterocycloalkyl; 
 R E6  is hydrogen, C 1 -C 6  alkyl, or a nitrogen protecting group; 
 each Y is independently O, S, CH 2 , or NR E7 ; 
 R E7  is hydrogen, C 1 -C 6  alkyl, or a nitrogen protecting group; 
 each R 9  is independently selected from the group consisting of halo, OH, NH 2 , NH(C 1 -C 6  alkyl), and N(C 1 -C 6  alkyl) 2 ; 
 a is 0, 1, or 2; and 
 z is 1, 2, or 3; 
 alternatively, R 3  is
                     
 wherein n is 0, 1, 2, 3, 4, or 5.

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